Coya Therapeutics Secures $5M Investment from ADDF

Coya Therapeutics, Inc., a biotechnology company specializing in the development of biologics aimed at enhancing regulatory T cell (Treg) function, has announced a significant investment from the Alzheimer’s Drug Discovery Foundation (ADDF). The ADDF has acquired 603,136 shares of Coya’s common stock at $8.29 per share, totaling an investment of $5 million. This funding will support the advancement of Coya’s leading therapeutic candidate, COYA 302, particularly in its application for treating Frontotemporal Dementia (FTD).

The ADDF is renowned for its mission to accelerate the development of drugs to prevent, treat, and cure Alzheimer’s disease and related dementias. This investment aligns with their strategy, as COYA 302 is being prepared for a Phase 2 trial for FTD. Dr. Howard Fillit, Co-Founder and Chief Science Officer of ADDF, highlighted the importance of combination therapies in addressing complex diseases like FTD. COYA 302, which targets multiple inflammatory pathways to suppress neuroinflammation, exemplifies this approach.

Coya Therapeutics’ CEO, Dr. Howard Berman, expressed gratitude for the ADDF’s support. He emphasized that both organizations share a vision that combination therapies represent the future of treating Alzheimer’s and similar dementias. The ADDF’s scientists have rigorously evaluated COYA 302, which aims to tackle the pronounced inflammatory responses in FTD. Dr. Berman looks forward to potentially revolutionizing treatment paradigms for these patients in collaboration with the ADDF.

Dr. Berman also noted that many neurodegenerative diseases, including Alzheimer’s, FTD, Parkinson’s disease, and ALS, share common pathways like neuroinflammation and neuronal loss, leading to cognitive and motor dysfunctions. These conditions often involve the body’s immune system and anti-inflammatory regulatory Tregs. Traditional approaches that target a single disease or pathway might not be sufficient for these complex diseases. However, COYA 302 has shown promising results in targeting multiple immune pathways, potentially offering sustained and lasting effects.

COYA 302 is an investigational biologic combination therapy that includes low dose interleukin-2 (LD IL-2) and CTLA4-Ig (abatacept). It is designed for subcutaneous administration and aims to enhance Treg function while suppressing inflammation caused by activated monocytes and macrophages. This dual mechanism could have additive or synergistic effects.

Earlier in 2023, Coya presented results from a proof-of-concept study conducted at Houston Methodist Hospital, involving patients with ALS. The study, which lasted for 48 weeks, showed that the therapy was well tolerated, with only mild injection-site reactions reported. No serious adverse events or deaths occurred. The patients’ disease progression, measured by the ALSFRS-R scale, indicated significant stabilization over the treatment period, suggesting a potential slowing of disease progression.

Moreover, the study found a statistically significant increase in Treg suppressive function over the treatment period, which decreased after an 8-week washout period, indicating a durable enhancement of Treg function during treatment. Additionally, serum biomarkers related to inflammation and oxidative stress showed a decrease, aligning with the improved Treg function.

COYA 302 is still under investigation and has not yet received FDA approval. The investment from ADDF marks a significant step in developing this promising therapeutic approach, which could eventually introduce a new treatment paradigm for neurodegenerative diseases.

Frontotemporal Dementia (FTD) is a rare and progressive condition affecting the frontal and temporal brain lobes, leading to symptoms such as behavioral changes, emotional problems, and communication difficulties. It tends to manifest in people aged 45 to 64 and currently has no cure, with symptoms worsening over time and varying widely among patients.

Alzheimer’s disease, the most prevalent cause of dementia, affects millions of Americans, primarily those over 60. It is a progressive disease leading to severe cognitive decline and is a major cause of death among older adults. There is no cure, and current treatments only offer limited relief of symptoms.

The Alzheimer’s Drug Discovery Foundation, established in 1998, focuses solely on funding the development of drugs for Alzheimer’s. The foundation has significantly contributed to bringing new diagnostic tools and treatments to market and continues to support innovative research in the field.

Coya Therapeutics is based in Houston, TX, and is dedicated to developing treatments targeting systemic and neuroinflammation through various therapeutic modalities. Their lead product, COYA 302, represents a novel approach aiming to restore immune balance and reduce inflammation in patients with neurodegenerative diseases.